Long-Term Efficacy of Teprotumumab in Thyroid Eye Disease: Follow-Up Outcomes in Three Clinical Trials
Authors' conclusion
The long-term response to teprotumumab as observed 51 weeks after therapy was similar to week 24 results in the controlled clinical trials. Inflammatory and ophthalmic composite outcome improvements were seen in 90% of patients with nearly 70% reporting improvement in diplopia and proptosis. Further, 82% of patients in this analysis did not report additional TED treatment (including surgery) over 99 weeks following the final teprotumumab dose.
Study context
- Population
- Patients with thyroid eye disease (TED) who received 7 or 8 teprotumumab infusions in the Phase 2, Phase 3 (OPTIC) and OPTIC-X studies3 trials pooled
- Participants
- 112 patients
Methodological detailsPhase 2, Phase 3 (OPTIC) and OPTIC-X studies, long-term follow-up, Studies differed in the timing of follow-up visits, and data from some visits were unavailable
- Phase 2, Phase 3 (OPTIC) and OPTIC-X studies
- Long-term follow-up
- Studies differed in the timing of follow-up visits, and data from some visits were unavailable
Primary result
As reported in the abstract
- CAS responders (≥2-point improvement)
- 52/57 (91.2%)
- Ophthalmic composite outcome responders
- 51/57 (89.5%)
- Diplopia responders (≥1 Gorman grade improvement)
- 35/48 (72.9%)
- Proptosis responders (≥2 mm improvement)
- 38/56 (67.9%)
- Overall responders (proptosis + CAS)
- 37/56 (66.1%)
Further findings
Mean reduction in proptosis · up to week 72
- Mean reduction in proptosis (SD 1.92, n = 56)
- 2.68 mm
Graves' Ophthalmopathy quality-of-life (GO-QoL) improvement · up to week 72
- Mean GO-QoL improvement (SE 2.82, n = 56)
- 15.22
Disease inactivation (CAS ≤1) · up to week 72
- Disease inactivation (CAS ≤1)
- 40/57 (70.2%)
Additional TED therapy · over 99 weeks following teprotumumab therapy
- Patients reporting additional TED therapy during formal and extended follow-up
- 19/106 (17.9%)
Original publication
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